The drug-discovery process is inefficient and paper-laden. The SAFE initiative hopes to digitize electronic signatures to shave years and millions of dollars off the cost of bringing a drug to market.

From the lab to the pharmacy:

• 10-12 years of clinical trials and research
• 6.5 million pages of data
• Separate authentication creden-tials for each company
• $1.1 billion total cost

What SAFE Baseline Version 1.0 standard can do:

• Standardize digital credentials that pass regulatory muster.
• Cut costs of managing up to a dozen credentials per researcher.
• Provide more security with less manual validation.
• Trim up to 5 percent off drug's discovery time.
• Save $1 million for each day cut from discovery process.

Pilots Take Off
The SAFE standard will make it possible for the industry to comply with 21 CFR Part 11, an FDA regulation that governs electronic record-keeping and signatures.

Small-scale pilot projects using the standard are underway, says SAFE's Tallent; he believes widespread adoption of the standard will begin next year.

SAFE digital signatures have already simplified life for Robert J. Mo...

The City of Hope began using SAFE credentials several months ago to file electronic documents for National Cancer Institute programs and other paperwork-intensive clinical research. "It's just as easy, if not easier, for me to use this system than to use paper. And it saves our staff an enormous amount of time preparing paperwork," he says.

To access the system, Morgan inserts his smart card and enters his username and password. To sign electronic medical documents, he clicks where his signature would have been required in the past; each time he electronically signs a document, his smart card must be in the reader and he must reenter his password.

"There's absolutely no paper involved," Morgan says.

Soon, Bristol-Myers Squibb will roll out an authenti-cation and digital signature pilot based on SAFE by distributing CyberTrust smart cards to about 20 re-searchers and support staff at one of its CROs. These users will be to externally access Bristol-Myers' research applications to view and update data. To gain access, users will be prompted to swipe their smart card and enter their PIN. Once authenticated, they'll be connected through a VPN.

"It sounds simple," Bristol-Myers's Yborra says. "Everything always looks good on paper, but the purpose of a pilot is to make sure the technology is there and the business process works."

Yborra believes that PKI technology has been proven for years, but nailing the business process is the biggest challenge. In these types of implementations, that means deciding what actually needs to be signed as part of the approval and regulatory process.

"We pick up the pen and sign many things that don't legally need to be signed. It's more just a check of approval," he says. That may not be a big deal in the world of paper, but tooling business technology systems and documents to accept digital signatures takes a lot of IT effort. Yborra likens it to users logged into an ERP system. "Sometimes in the process all you need is to check something off, based on your user name and password. Sometimes you need to bind a signature to an electronic document for five, 10 or 20 years. Those are the ones we're looking for." And each paper signature the biopharmaceutical industry can find and digitize could slash the cost of drug development by billions. "That's a lot of trees that could be saved," says Yborra.

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